Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01414608
First received: August 10, 2011
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.


Condition Intervention Phase
Cervical Adenocarcinoma
Cervical Adenosquamous Cell Carcinoma
Cervical Squamous Cell Carcinoma
Chemotherapeutic Agent Toxicity
Cognitive/Functional Effects
Psychosocial Effects of Cancer and Its Treatment
Radiation Toxicity
Sexuality and Reproductive Issues
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IVA Cervical Cancer
Drug: cisplatin
Drug: paclitaxel
Drug: carboplatin
Radiation: external beam radiation therapy
Radiation: brachytherapy
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Overall survival rate [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
    Described with Kaplan-Meier curves and unadjusted logrank tests.


Secondary Outcome Measures:
  • Progression-free survival rate [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival rate [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Rate of acute and long-term toxicities [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Patterns of disease recurrence [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Radiation protocol compliance [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Quality of life including psychosexual health [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 780
Study Start Date: January 2012
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (cisplatin, radiation therapy, brachytherapy)
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy.
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Radiation: external beam radiation therapy
Undergo external beam radiation therapy
Other Name: EBRT
Radiation: brachytherapy
Undergo brachytherapy
Other Names:
  • low-LET implant therapy
  • radiation brachytherapy
  • therapy, low-LET implant
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm II (cisplatin, radiation therapy, brachytherapy, chemo)
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Radiation: external beam radiation therapy
Undergo external beam radiation therapy
Other Name: EBRT
Radiation: brachytherapy
Undergo brachytherapy
Other Names:
  • low-LET implant therapy
  • radiation brachytherapy
  • therapy, low-LET implant
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves overall survival.

SECONDARY OBJECTIVES:

I. To determine the progression-free survival rates. II. To determine acute and long-term toxicities. III. To determine patterns of disease recurrence. IV. To determine the association between radiation protocol compliance and outcomes.

V. To determine patient quality of life, including psycho-sexual health.

TERTIARY OBJECTIVES:

I. To determine the association between the results of a follow-up positron emission tomography (PET) scan performed 4-6 months post completion of chemoradiation and outcomes for all patients in the trial.

II. To determine the biological predictors of patients' outcomes based on translational laboratory studies of blood and tissue specimens.

OUTLINE: This is a multicenter study. Patients are stratified according to pelvic or common iliac nodal involvement (yes vs no), requirement for extended-field radiotherapy treatment (yes vs no), International Federation of Gynecology and Obstetrics (FIGO) stage (IB/IIA vs IIB vs IIIB/IVA), age (< 60 years of age vs >= 60 years of age), and hospital/site. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy.

ARM II: Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients may undergo baseline tumor biopsy and blood collection for future correlative studies.

Patients complete the European Organization for Research and Treatment of Cancer (EORTC) Core questionnaire (QLQ-C30), the EORTC cervix cancer module (CX24), the ovarian cancer module (OV28), and the Sexual function-Vaginal Changes Questionnaire (SVQ) questionnaires at baseline, during, and after completion of study treatment.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients will have locally advanced cervical cancer suitable for primary treatment with chemoradiation with curative intent, in addition to:

    • Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix
    • FIGO 2008 stage IB1 & node positive, IB2, II, IIIB, or IVA disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
  • White blood cells (WBC) >= 3.0 x 10^9/L
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Platelet count >= 100 x 10^9/L
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN
  • Creatinine =< ULN (Common Toxicity Criteria [CTC] Grade 0) OR calculated creatinine clearance (Cockcroft-Gault Formula) >= 60 mL/min OR >= 50 mL/min by ethylenediaminetetraacetic acid (EDTA) creatinine clearance
  • Written informed consent

Exclusion Criteria:

  • Any previous pelvic radiotherapy
  • Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive, or >= 15 mm short-axis diameter on computed tomography [CT])
  • FIGO 2008 stage IIIA disease
  • Patients assessed at presentation as requiring interstitial brachytherapy treatment
  • Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria
  • Previous chemotherapy for this tumor
  • Evidence of distant metastases
  • Prior diagnosis of Crohn disease or ulcerative colitis
  • Peripheral neuropathy >= grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] v. 4)
  • Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years
  • Patients who are pregnant or lactating
  • Any contraindication to the use of cisplatin, carboplatin, or paclitaxel chemotherapy
  • Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Human immunodeficiency virus (HIV) positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414608

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Warner K. Huh    205-934-0309      
Principal Investigator: Warner K. Huh         
University of South Alabama Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36688
Contact: Rodney P. Rocconi    251-445-9870    pfrancisco@usouthal.edu   
Principal Investigator: Rodney P. Rocconi         
United States, Arizona
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: John H. Farley    877-602-4111      
Principal Investigator: John H. Farley         
United States, California
John Muir Medical Center-Concord Campus Active, not recruiting
Concord, California, United States, 94520
Palo Alto Medical Foundation-Gynecologic Oncology Recruiting
Mountain View, California, United States, 94040
Contact: Albert L. Pisani    650-934-7000      
Principal Investigator: Albert L. Pisani         
University of California Medical Center At Irvine-Orange Campus Active, not recruiting
Orange, California, United States, 92868
Saint Joseph Hospital - Orange Recruiting
Orange, California, United States, 92868
Contact: Michael L. Berman    877-827-8839    ucstudy@uci.edu   
Principal Investigator: Michael L. Berman         
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Gary S. Leiserowitz    916-734-3089      
Principal Investigator: Gary S. Leiserowitz         
Olive View-University of California Los Angeles Medical Center Recruiting
Sylmar, California, United States, 91342
Contact: Christine H. Holschneider    888-798-0719      
Principal Investigator: Christine H. Holschneider         
John Muir Medical Center Active, not recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Susan A. Davidson    720-848-0650      
Principal Investigator: Susan A. Davidson         
Penrose-Saint Francis Healthcare Active, not recruiting
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
University of Connecticut Recruiting
Farmington, Connecticut, United States, 06030
Contact: Angela S. Kueck    800-579-7822      
Principal Investigator: Angela S. Kueck         
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: James S. Hoffman    860-224-5660      
Principal Investigator: James S. Hoffman         
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: James S. Hoffman    860-224-5660      
Principal Investigator: James S. Hoffman         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Peter E. Schwartz    203-785-5702      
Principal Investigator: Peter E. Schwartz         
United States, Delaware
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Mark E. Borowsky    302-733-6227      
Principal Investigator: Mark E. Borowsky         
United States, Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Joseph A. Lucci    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Joseph A. Lucci         
United States, Georgia
Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Contact: Joseph W. Shelton    404-489-9164      
Principal Investigator: Joseph W. Shelton         
Emory University/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Joseph W. Shelton    404-489-9164      
Principal Investigator: Joseph W. Shelton         
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Sahar E. Rosenbaum    404-303-3355      
Principal Investigator: Sahar E. Rosenbaum         
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Andrew E. Green    770-219-8800    cancerpatient.navigator@nghs.com   
Principal Investigator: Andrew E. Green         
Central Georgia Gynecologic Oncology Withdrawn
Macon, Georgia, United States, 31201
United States, Hawaii
Hawaii Minority Based CCOP Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Michael E. Carney    808-983-6090      
Principal Investigator: Michael E. Carney         
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Michael E. Carney    808-983-6090      
Principal Investigator: Michael E. Carney         
United States, Illinois
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612-3785
Contact: Harish V. Thakrar    312-864-6000      
Principal Investigator: Harish V. Thakrar         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Eric D. Donnelly    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Eric D. Donnelly         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Seiko D. Yamada    773-834-7424      
Principal Investigator: Seiko D. Yamada         
Sudarshan K Sharma MD Limted-Gynecologic Oncology Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Sudarshan K. Sharma    630-856-6757      
Principal Investigator: Sudarshan K. Sharma         
United States, Indiana
Indiana University Medical Center Active, not recruiting
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Gregory P. Sutton    317-338-2194      
Principal Investigator: Gregory P. Sutton         
United States, Kansas
University of Kansas Medical Center Active, not recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Hope M. Cottrill    859-260-6425      
Principal Investigator: Hope M. Cottrill         
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Frederick R. Ueland    859-257-3379      
Principal Investigator: Frederick R. Ueland         
Norton Health Care Pavilion - Downtown Recruiting
Louisville, Kentucky, United States, 40202
Contact: Mary E. Gordinier    502-629-2500      
Principal Investigator: Mary E. Gordinier         
United States, Louisiana
Ochsner Clinic CCOP Terminated
New Orleans, Louisiana, United States, 70121
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: William R. Robinson    504-988-6121      
Principal Investigator: William R. Robinson         
United States, Maine
Maine Medical Center-Bramhall Campus Recruiting
Portland, Maine, United States, 04102
Contact: Christopher J. Darus    207-885-7565      
Principal Investigator: Christopher J. Darus         
United States, Maryland
University of Maryland Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201-1595
Contact: Sarah M. Temkin    800-888-8823      
Principal Investigator: Sarah M. Temkin         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Michael P. Stany    301-319-2100      
Principal Investigator: Michael P. Stany         
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Tashanna K. Myers    413-794-3565    tamara.wrenn@baystatehealth.org   
Principal Investigator: Tashanna K. Myers         
University of Massachusetts Memorial Health Care Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Susan L. Zweizig    508-856-3216    cancer.research@umassmed.edu   
Principal Investigator: Susan L. Zweizig         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Thomas E. Buekers    313-916-1784      
Principal Investigator: Thomas E. Buekers         
Wayne State University-Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Robert T. Morris    313-576-9363      
Principal Investigator: Robert T. Morris         
West Michigan Cancer Center Active, not recruiting
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
University of Minnesota Medical Center-Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Peter A. Argenta    612-624-2620      
Principal Investigator: Peter A. Argenta         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Minnesota Oncology and Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: James T. Thigpen    601-815-6700      
Principal Investigator: James T. Thigpen         
United States, Missouri
Mercy Hospital Springfield Active, not recruiting
Springfield, Missouri, United States, 65804
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59107-7000
Contact: Randall K. Gibb    800-996-2663    research@billingsclinic.org   
Principal Investigator: Randall K. Gibb         
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Peter C. Morris    402-354-7939    kathryn.bartz@nmhs.org   
Principal Investigator: Peter C. Morris         
University of Nebraska Medical Center Terminated
Omaha, Nebraska, United States, 68198
United States, Nevada
Women's Cancer Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Nicola M. Spirtos    702-851-4672      
Principal Investigator: Nicola M. Spirtos         
United States, New Jersey
Cooper Hospital University Medical Center Recruiting
Camden, New Jersey, United States, 08103
Contact: David P. Warshal    856-325-6757      
Principal Investigator: David P. Warshal         
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Donna T. McNamara    201-996-2879      
Principal Investigator: Donna T. McNamara         
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Yana P. Goldberg    973-971-5900      
Principal Investigator: Yana P. Goldberg         
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Withdrawn
Mount Holly, New Jersey, United States, 08060
Jersey Shore Medical Center Active, not recruiting
Neptune, New Jersey, United States, 07753
Cancer Institute of New Jersey Terminated
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
Southwest Gynecologic Oncology Associates Inc Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Teresa L. Rutledge    505-272-6972      
Principal Investigator: Teresa L. Rutledge         
University of New Mexico Cancer Center Active, not recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Women's Cancer Care Associates LLC Recruiting
Albany, New York, United States, 12208
Contact: Thomas P. Morrissey    518-458-1390      
Principal Investigator: Thomas P. Morrissey         
State University of New York Downstate Medical Center Active, not recruiting
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Peter J. Frederick    877-275-7724      
Principal Investigator: Peter J. Frederick         
New York Hospital Medical Center of Queens Recruiting
Fresh Meadows, New York, United States, 11365
Contact: Manolis T. Tsatsas    718-670-1343      
Principal Investigator: Manolis T. Tsatsas         
Queens Hospital Center Recruiting
Jamaica, New York, United States, 11432
Contact: Mary M. Kemeny    718-883-3000      
Principal Investigator: Mary M. Kemeny         
Monter Cancer Center Active, not recruiting
Lake Success, New York, United States, 11042
North Shore University Hospital Active, not recruiting
Manhasset, New York, United States, 11030
Winthrop University Hospital Active, not recruiting
Mineola, New York, United States, 11501
Long Island Jewish Medical Center Active, not recruiting
New Hyde Park, New York, United States, 11040
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mario M. Leitao    212-639-7202      
Principal Investigator: Mario M. Leitao         
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Stephanie V. Blank    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Stephanie V. Blank         
Stony Brook University Medical Center Active, not recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
Cone Health Alamance Regional Medical Center Recruiting
Burlington, North Carolina, United States, 27216
Contact: Janak K. Choksi    336-538-7725      
Principal Investigator: Janak K. Choksi         
University of North Carolina Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Robert V. Higgins    704-355-2884      
Principal Investigator: Robert V. Higgins         
Carolinas Medical Center - Northeast Recruiting
Concord, North Carolina, United States, 28025
Contact: Brigitte E. Miller    704-403-1520      
Principal Investigator: Brigitte E. Miller         
New Hanover Regional Medical Center Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Walter H. Gajewski    910-342-3000      
Principal Investigator: Walter H. Gajewski         
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Recruiting
Akron, Ohio, United States, 44304
Contact: Vivian E. von Gruenigen    330-375-6101      
Principal Investigator: Vivian E. von Gruenigen         
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Eric L. Eisenhauer    513-558-4553    uchealthnews@uc.edu   
Principal Investigator: Eric L. Eisenhauer         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Cleveland Clinic Cancer Center/Fairview Hospital Active, not recruiting
Cleveland, Ohio, United States, 44111
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: David M. O'Malley    866-627-7616    osu@emergingmed.com   
Principal Investigator: David M. O'Malley         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Jeffrey G. Bell    614-566-4475      
Principal Investigator: Jeffrey G. Bell         
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Christopher V. Lutman    937-208-2387      
Principal Investigator: Christopher V. Lutman         
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Thomas J. Reid    937-298-3399    uchealthnews@uc.edu   
Principal Investigator: Thomas J. Reid         
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Lake University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
University of Toledo Active, not recruiting
Toledo, Ohio, United States, 43614
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
Tulsa Cancer Institute Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Parviz Hanjani    215-481-2402      
Principal Investigator: Parviz Hanjani         
Saint Luke's University Hospital-Bethlehem Campus Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Nicholas P. Taylor    610-954-3582    infolink@slhn.org   
Principal Investigator: Nicholas P. Taylor         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Pramila R. Anne    215-955-6084      
Principal Investigator: Pramila R. Anne         
Magee-Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Dwight E. Heron    412-647-8073      
Principal Investigator: Dwight E. Heron         
UPMC-Shadyside Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Dwight E. Heron    412-647-8073      
Principal Investigator: Dwight E. Heron         
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Bernice L. Robinson-Bennett    610-988-9323      
Principal Investigator: Bernice L. Robinson-Bennett         
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Paul A. DiSilvestro    401-274-1122      
Principal Investigator: Paul A. DiSilvestro         
United States, South Carolina
AnMed Health Cancer Center Recruiting
Anderson, South Carolina, United States, 29621
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jennifer L. Young Pierce    843-792-9321      
Principal Investigator: Jennifer L. Young Pierce         
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
Upstate Carolina CCOP Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
United States, South Dakota
Black Hills Obstetrics and Gynecology Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Helen L. Frederickson    605-343-9224      
Principal Investigator: Helen L. Frederickson         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: David S. Miller    214-648-7097      
Principal Investigator: David S. Miller         
University of Texas Medical Branch at Galveston Active, not recruiting
Galveston, Texas, United States, 77555-0565
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lois M. Ramondetta       lramonde@mdanderson.org   
Principal Investigator: Lois M. Ramondetta         
M D Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
Memorial Hermann Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Larissa A. Meyer       sgriffin@gog.org   
Principal Investigator: Larissa A. Meyer         
Lyndon Baines Johnson General Hospital Recruiting
Houston, Texas, United States, 77026-1967
Contact: Lois M. Ramondetta    713-792-3245      
Principal Investigator: Lois M. Ramondetta         
United States, Utah
Dixie Medical Center Regional Cancer Center Recruiting
Saint George, Utah, United States, 84770
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Matthew M. Poppe    801-581-4477    clinical.trials@hci.utah.edu   
Principal Investigator: Matthew M. Poppe         
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: R. J. Lee    801-507-3950      
Principal Investigator: R. J. Lee         
United States, Virginia
University of Virginia Active, not recruiting
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Weldon E. Chafe    804-628-1939      
Principal Investigator: Weldon E. Chafe         
Carilion Clinic Gynecological Oncology Active, not recruiting
Roanoke, Virginia, United States, 24016
United States, Wisconsin
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311-6519
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Kristin A. Bradley    877-405-6866      
Principal Investigator: Kristin A. Bradley         
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: William H. Bradley    414-805-4380      
Principal Investigator: William H. Bradley         
Vince Lombardi Cancer Clinic - Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Aurora Women's Pavilion of Aurora West Allis Medical Center Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Canada, Ontario
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: David P. D'Souza    519-685-8600      
Principal Investigator: David P. D'Souza         
Saudi Arabia
King Faisal Specialist Hospital and Research Centre Active, not recruiting
Riyadh, Saudi Arabia, 11211
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Kathleen Moore Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01414608     History of Changes
Other Study ID Numbers: ANZGOG-0902/GOG-0274/RTOG-1174, NCI-2011-02978, CDR0000706698, GOG-0274, RTOG-1174, ANZGOG-0902, ANZGOG-0902/GOG-0274/RTOG-1174, ANZGOG-0902-GOG-0274, U10CA027469
Study First Received: August 10, 2011
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Radiation Injuries
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Wounds and Injuries
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 01, 2014